Catalog Number

PC23AASMO

Brand Name

CARDINAL HEALTH

Version/Model Number

PC23AASMO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

5257b25a-2bb4-46fa-9293-fcddfb1185a5

Public Version Date

July 20, 2018

Public Version Number

3

DI Record Publish Date

September 03, 2015

Package DI Number

50887488006077

Quantity per Package

1

Contains DI Package

00887488006072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE